A Randomised Controlled Trial to Investigate the Effects of Parental Touch on Relieving Acute Procedural Pain in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Magnitude of noxious-evoked brain activity
研究概览
简要总结
This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.
详细描述
This is a multicentre randomised-controlled interventional trial, with two research sites (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital, Devon). In this study we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia.
The primary objective is to determine whether parental touch reduces noxious-evoked brain activity following a heel lance. In addition, our secondary and exploratory objectives include investigating the effect of touch on behavioural and electrophysiological measures evoked by a heel lance. Neonates will be randomised to receive parental touch either prior to or post a clinically required heel lance. We will also investigate how parental touch impacts post-procedural clinical stability and explore whether this intervention affects parental anxiety.
Neonates will be recruited during a 9-month period. Participants will be studied on a single test occasion while they are in hospital, when they require a clinical heel lance. No extra blood tests or noxious procedures will be performed for the purpose of the study. Participants will be included in the study for approximately an hour period. This will be approximately 30 min before and after the time when the heel lance is performed. Individual babies will only be included in the trial once. If a neonate requires additional heel lances to acquire sufficient blood for clinical assessment at the time of the test occasion, we will also record the responses to this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants born at the John Radcliffe Hospital, Oxford or the Royal Devon and Exeter Hospital, Devon
- •Neonates born at or after 35+0 weeks gestation
- •Neonates with a postnatal age of 7 days or less
- •Neonates who clinically require a heel lance
- •Neonates for whom parents/guardians have given written informed consent for inclusion in the trial
排除标准
- •Intraventricular haemorrhage (IVH) > grade II
- •Received any analgesics or sedatives in the last 24 hours
- •Congenital malformation or genetic condition known to affect neurological development
- •Born to mothers who have a history of substance abuse.
结局指标
主要结局
Magnitude of noxious-evoked brain activity
时间窗: Immediately after heel lance (within 1000ms)
An electroencephalography (EEG) template based on the Principal Component that reflects the noxious-evoked brain activity in neonates has been defined and validated in independent data sets (Hartley 2017). This template will be projected onto the EEG data recorded in the 1000ms period following each heel lance and heel lance control stimulus and the relative weight of the component calculated for each neonate. A greater weight indicates a stronger noxious-evoked response.
次要结局
- Premature Infant Pain Profile - Revised score (PIPP-R score)(During the 30s period after the heel lance)
- Percentage of neonates who develop tachycardia(During the 30s period after the heel lance)
- Parental anxiety(At the end of the test occasion, within 30 minutes of the heel lance)
研究者
Rebeccah Slater
Professor of Paediatric Neuroscience
Paediatric Neuroimaging Research Group